Kornimate/medical-research-clean huggingface dataset:
blod biomarkers for stroke

Conditions: Stroke

Summary: the purpose of the project is to investigate specific markers in blood samples from patients with stroke (ischemic or hemorrhagic). this could hopefully help in the early diagnostic to separate patients with ischemic stroke from those with hemorrhagic stroke as treatment are different and patients need to come quickly to the correct treatment site.

approximately 12,000 danes suffer a stroke each year with major consequences for those affected, their relatives and society in general. rapid diagnosis and treatment mean less brain damage and thus less risk of late sequelae. a marker in the blood that is specific for stroke could result in faster diagnose and thereby treatment. until now, no such marker has been found, but measurement of the so-called metabolomics and different fragments of brain proteins like tau has shown promising results. currently, metabolomics has only been studied in two other projects in stroke patients, and the results were not complete and a subtype of tau (tau-c) has been shown to be related to brain damage after ice hockey, but this is not studied in stroke patients, so there is a need for more studies. in this project different fragments of brain proteins and the so-called metabolomics in the blood, which are small residues from the biological processes that take place in the body, such as fat and sugar incineration, will be studied. the project is based on blood samples from a biobank that has been established in connection with previous projects in the stroke unit, neurological clinic, rigshospitalet, glostrup. all subjects have given written consent to give blood for future research. fifty microliters of blood from each participant will be analyzed by so-called mass spectroscopy, a well-researched method and performed in a recognized laboratory using known libraries and databases of metabolites for the determination and ongoing quality control. in addition, 250 microliters of serum will be analyzed by elisa to detect brain proteins like tau and brevican. the metabolomic profile and the brain proteins is compared to the information we have about the participants, namely: * if they had ischemic or hemorrhagic stroke or if it is a healthy control person * the extent of brain damage; partly measured by the brain scan and partly from the patient's symptoms * the cause of the stroke

Eligibility criteria:
inclusion criteria: * clinical stroke exclusion criteria: * glasgow coma scale (gcs) \< 15 * non communicating patients e.g. aphasia (incompetent patients) * unable to cooperate to the physical examinations * pregnancy or nursing mothers * if the investigators find the study participant unfit to conduct the investigations

Keywords: metabolomics tau ischemic stroke hemorrhagic stroke
ddep for lifestyle modification in chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: this is a randomized controlled feasibility trial conducted on patients with chronic kidney disease (ckd) and their significant other

the trial will be conducted on 60 dyads, each comprising a ckd patient and a significant other, who will be randomly assigned into two groups. the intervention group will receive the digital dyadic empowerment program (ddep) while the control group will receive routine education and care.

Eligibility criteria:
inclusion criteria: 1. the patient has a diagnosis of chronic kidney disease for at least six months; 2. the patient can identify a helpful significant other and both parties are willing to participate; 3. the patient can communicate in mandarin or taiwanese. exclusion criteria: 1. the significant other is a healthcare provider; 2. the patient or the significant other has a mental illness diagnosis; 3. the patient is currently receiving renal replacement therapies.

Keywords: feasibility studies digital health healthy lifestyle
improved icu outcomes with protocolized management of analgesia, sedation and delirium

Conditions: Critical Care

Summary: to assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.


Eligibility criteria:
inclusion criteria: * all adult patients admitted to icu exclusion criteria: * repeat admission within the same hospitalisation; moribund patients

Keywords: protocol analgesia sedation delirium coma
easyx-1 : a multicenter study on safety and efficacy of easyx liquid embolization agent used in five separate indications

Conditions: Varicocele; Endoleak; Portal Vein Thrombosis; Bleeding; Angiomyolipoma

Summary: the easyx™ liquid embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under x-ray guidance. the embolic liquid is an iodinized polyvinyl alcohol (pva) polymer ether. iodine groups are covalently grafted to the pva polymer backbone, whereby a stable nondegradable polymer with the desired features is created. the resulting polymer is dissolved in dimethyl sulfoxide (dmso). easyx™ is ce-marked since december 2016 and has been used in humans a few time for type ii endoleaks, portal vein and varicocele (\<10 cases at the date of submission). the purpose of this study is to evaluate the safety and efficacy of easyx™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type ii endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (aml).


Eligibility criteria:
inclusion criteria: * patient presenting with indication of varicocele, type ii endoleaks, portal vein, aml or active embolization with a liquid agent * aged ≥ 18 years * affiliated to a french health insurance system exclusion criteria: * hypersensitivity to polyvinyl alcohol (pva) polymer * hypersensitivity to dmso solvent * patient unable or unwilling to provide a written informed consent * patient participating in another interventional study * pregnant or breastfeeding woman * prisoners

Keywords: liquid embolics
delivra-celecoxib 8% cream and osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the observation of the clinical use of the delivra celecoxib cream (8%) in the treatment of osteoarthritis of the knee. observations will be made over 12 weeks of treatment. evaluations include: pain, functionality and patients global assessment of disease. patients will self administer treatment as prescribed.


Eligibility criteria:
inclusion criteria: * written informed consent * patients with primary osteoarthritis (with radiological evidence) of the knees who have been prescribed del-cel. * on stable pain therapy with an oral or topical nsaid or acetaminophen. * able to read and understand english to answer pain assessment questions independently. * willing and able to fulfill the requirements of the study, including complete scheduled follow-up phone visits. exclusion criteria: * inability to adequately read and understand english as required to complete study assessments and comply with the protocol. * current recreational or medicinal use of cannabis within 4 weeks of study initiation. * participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder) will be excluded. * participants with a lifetime history of daily cannabis use will be excluded. * dose changes of concomitant medication will not be permitted during the study period. * pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., iud, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant. * diagnosis of any of the following mental disorders as defined by the dsm-5: a lifetime history of schizophrenia or any other psychosis, organic medical disorders, bipolar disorder. entry of patients with obsessive compulsive disorder or post- traumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. * major depression will be allowed if not severe (montgomery åsberg depression rating scale-madrs27≥ 25). patients with significant suicidal ideation (madrs item 10 score \> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention. * participants with a family history of schizophrenia spectrum or bipolar disorder will be excluded. * participants who have a history of adverse reactions to cannabis will be excluded. * known allergy to any of the ingredients in the delivra base. * use of rimonabant (sr141716) within three weeks of enrollment and/or planned use for the duration of the study participation\[27\]. * use of 5-ht1a receptor antagonists (ssri inhibitors) within three weeks of enrollment and/or planned use for the duration of the study participation, e.g.: pindolol, lecozotan, brexpiprazole, etc.

Keywords: pain, womac
biostream.hf heartinsight

Conditions: Heart Failure

Summary: the main goal is to learn how heartinsight is used in clinical routine care. heartinsight is a heart failure monitoring and notification tool within biotronik's home monitoring system. heartinsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. this study will create a sound and seamless documentation of approximately 150 heartinsight alerts, their processing, subsequent interventions and disease progressions. the data will be analyzed to characterize and quantify the use of heartinsight in a clinical routine set-up.the patient population consists of heart failure patients with biotronik crt-d devices that support heartinsight.


Eligibility criteria:
inclusion criteria: * patient willing and able to give consent * participation in bio\|stream.hf * heartinsight-capable crt-d device implanted or planned to be implanted * symptomatic heart failure nyha class ii or iii within 45 days prior to enrollment * heartinsight score available or planned use of heartinsight * history of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure * patient is willing and able to utilize biotronik home monitoring via cardiomessenger and has sufficient mobile network coverage exclusion criteria: * patient with permanent atrial fibrillation or 100% atrial pacing * patient is not implanted with an atrial or dx lead or atrial sensing is deactivated * history of patient incompliance
to demonstrate the relative bioequivalency study of dosage forms of clemastine 2.68 mg tablets

Conditions: Allergy

Summary: to demonstrate the relative bioequivalency study of dosage forms of clemastine 2.68 mg tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antihistamine
nevanimibe hcl for the treatment of classic cah

Conditions: Congenital Adrenal Hyperplasia

Summary: this is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (hcl) for the treatment of classic congenital adrenal hyperplasia (cah). following a screening period of approximately 2-14 weeks, eligible subjects will enter a baseline period of approximately 2-8 weeks and then a 16-week treatment period. it is anticipated that the overall duration of the study per subject will range from 24-42 weeks.


Eligibility criteria:
inclusion criteria: * documented historical diagnosis of classic cah due to 21-hydroxylase deficiency and/or historical documentation of elevated 17-ohp * chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to screening * stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to screening and throughout the treatment period of the study exclusion criteria: * nonclassic cah * other causes of adrenal insufficiency * hiv, hepatitis b, or hepatitis c * ast or alt \>2x uln, bilirubin or serum creatinine \>1.5x uln

Keywords: cah nevanimibe
whole body electromyostimulation and nutritional therapy for patients with esophageal and bronchial carcinoma

Conditions: Cancer of Esophagus; Cancer, Lung

Summary: the objective or the trial is to study the influence of a combined therapy involving protein-rich individualized nutritional therapy and highly effective muscle training via personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality, physical capability, fatigue and quality of life in patients with esophageal and bronchial carcinoma in advanced or metastatic stage.

tumor specific and inflammation promoting mediators lead to a loss of appetite, to systemic inflammation processes and to metabolic and hormonal changes including anabolic resistance. consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of muscles and/or fat leading to cancer cachexia. in addition, an accelerated muscle wasting can be a side effect of the oncologic therapy promoting cancer cachexia even further. the advancing muscle loss induces diminishing physical capability, a decreased tolerance of oncological therapy, functional losses even reaching loss of independence and a worsened prognosis. the purpose of this study is to establish an innovative combined therapy involving protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (wb-ems) exercise to improve muscle mass, functionality and strength of esophageal and bronchial carcinoma patients in advanced stage. an increase in muscle mass and strength leads to an increase in physical activity, physical capability as well as tolerance to and applicability of tumor therapy. in the course of a 3-months intervention study the efficacy of a combined protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with esophageal and bronchial carcinoma in advanced or metastatic stage. an effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his quality of life and tolerability of oncological treatment.

Eligibility criteria:
inclusion criteria: * patients with esophageal and/or bronchial carcinoma in curative or palliative treatment exclusion criteria: * healthy persons or patients under age * pregnancy, lactation * psychological disorders, epilepsia, sever neurological disorders * participation in other exercise- or nutrition studies within the last 6 months * acute cardiovascular disease * rheuma * intake of anabolic drugs, * skin injuries in the area of electrode placements * electronic implants (defibrillator, pacemaker) * persons in mental hospitals by order of authorities or jurisdiction
the clinical trial to investigate the pharmacokinetics and safety/tolerability of ckd-387 under fed condition

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of ckd-387 and d484 under fed condition in healthy adults.


Eligibility criteria:
inclusion criteria: 1. healthy adults aged 19 to 55 years 2. females must be menopause or surgical infertility 3. signed informed consent form 4. other inclusion criteria, as defined in the protocol exclusion criteria: 1. history of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder 2. clinical laboratory test values are outside the accepted normal range at screening * aspartate aminotransferase(ast), alanine aminotransferase(alt) \> 1.25 times the upper limit of the normal range * total bilirubin \> 1.5 times the upper limit of the normal range * creatine phosphokinase(cpk) \> 1.5 times the upper limit of the normal range * estimated glomerular filtration rate(egfr, mdrd\* formula) \< 60 ml/min/1.73m2 (\*mdrd: modification of diet in renal disease) * positive reaction on following tests: hepatitis b, hepatitis c, human immunodeficiency virus(hiv) and syphilis * systolic blood pressure(sbp) ≥ 150 mmhg or \ 100 mmhg or \< 50 mmhg 3. subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization 4. participated in a clinical trial within 90 days prior to 1st ip dosing 5. not eligible to participate for the study at the discretion of investigator 6. other exclusive inclusion criteria, as defined in the protocol
intraoperative hypovolemia and fluid therapy

Conditions: Hypovolemia; Organ Dysfunction

Summary: postoperative organ dysfunction severely affects the prognosis of surgical patients. despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains controversial. owing to the risk of altered tissue perfusion, a key trigger of organ dysfunction, the purpose of this study was to compare the influence of restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and postoperative organ dysfunction.

despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains unanswered. although recent studies suggest that intraoperative fluid restriction may reduce postoperative morbidity and promote faster recovery, extrapolation to individual patients remains difficult. indeed, whether fluid overload may expose tissue to oedema, impairing oxygenation and wound healing, fluid restriction may, conversely, expose to hypovolemia, which occurs frequently during abdominal surgery, leading to tissue hypoperfusion and organ dysfunction. to date, the restrictive and liberal fluid substitution strategies have not been compared using a goal-directed approach. in addition, recent data suggest that targeting early indicators of hypoperfusion, such as central venous oxygen saturation (scvo2), which reflects the oxygen delivery/consumption relationship, may be important in the management of patients undergoing major surgery. no data are available on the effects of intraoperative fluid volume replacement strategy on scvo2 modifications. the purpose of this study is first to evaluate the influence of restrictive and liberal fluid replacement strategies on both hypovolemia and postoperative organ dysfunction using an oesophageal doppler goal-directed approach (with goal = peak aortic velocity variation and stroke volume optimization) during major abdominal surgery. the second objective is to investigate the effects of fluid loading on scvo2 modifications.

Eligibility criteria:
inclusion criteria: * major intraabdominal surgery exclusion criteria: * age \< 18 years * pregnancy * body mass index \> 35 kg/m2 * emergency surgery * coagulopathy * sepsis or systemic inflammatory response syndrome (sirs) * hepatic failure (prothrombin ratio \< 50%, factor v \< 50%) * contraindication for epidural analgesia

Keywords: intraoperative fluid monitoring oesophageal doppler abdominal surgery major abdominal surgery
venous thromboembolic event (vte) prophylaxis in medically ill patients

Conditions: Venous Thromboembolism

Summary: this study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. the safety of rivaroxaban will also be studied.

the treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on day 90 (+ 7 days). participants who did not complete the treatment period also entered the follow-up period. it was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation. within the us 'johnson \& johnson pharmaceutical research \& development, l.l.c.' is sponsor.

Eligibility criteria:
inclusion criteria: * male and female patients aged 40 years or more * patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows: * heart failure, new york heart association (nyha) class iii or iv * active cancer * acute ischemic stroke * acute infectious and inflammatory diseases, including acute rheumatic diseases * acute respiratory insufficiency * additional risk factor for vte, including reduced mobility exclusion criteria: * conditions that contraindicate the use of antithrombotic therapy with the low molecular-weight heparin (lmwh) enoxaparin * conditions that may increase the risk of bleeding, including intracranial hemorrhage * required drugs or procedures which may interfere with the study treatment * concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome * general conditions in which subjects are not suitable to participate in the study

Keywords: acute medical illnesses with increased risk for vte. deep vein thrombosis (dvt) pulmonary embolism (pe), venous thromboembolic disease (vte), medical illness